ISSUE REPORT CLOSING THE VACCINATION GAP: A Shot ...ISSUE REPORT CLOSING THE VACCINATION GAP: A Shot in the Arm for Childhood Immunization Programs AUGUST 2004 TRUST FOR AMERICA’S

I S S U E R E P O R T

CLOSING THE VACCINATION GAP:

A Shot in the Arm for ChildhoodImmunization Programs

AUGUST 2004

PREVENTING EPIDEMICS.PROTECTING PEOPLE.

TRUST FOR AMERICA’S HEALTH IS A NON-PROF-

IT, NON-PARTISAN ORGANIZATION DEDICATED

TO SAVING LIVES BY PROTECTING THE HEALTH OF

EVERY COMMUNITY AND WORKING TO MAKE DIS-

EASE PREVENTION A NATIONAL PRIORITY.

ACKNOWLEDGEMENTS:This report was written in partnership withEvery Child By Two: The Carter/BumpersCampaign for Early Immunization.www.ecbt.org.

A U G U S T 2 0 0 4

AUTHORS

Betty BumpersFormer First Lady of AkansasCofounder Vice PresidentEvery Child By TwoThe Carter/Bumpers Campaign forEarly Immunization

Shelley A. Hearne, DrPHExecutive DirectorTrust for America’s Health

Dan SegalPartnerFifth Floor Partners

Patti J. UnruhSenior Communications AssociateTrust for America’s Health

Amy Pisani, MSExecutive DirectorEvery Child By Two

Jennifer Zavolinsky, MHS, CHESSenior Manager, Immunization OutreachInitiativesEvery Child By Two

CONTRIBUTORS

Michael J. EarlsCommunications SpecialistTrust for America’s Health

Kim ElliottDeputy DirectorTrust for America's Health

Laura Segal, MADirector of Public AffairsTrust for America's Health

PEER REVIEWERS:

Claire Hannan, MPHExecutive DirectorAssociation of ImmunizationManagers

Marcy Connell JonesChiefInformation and Education SectionImmunization BranchCalifornia Department of HealthServices

Paul Offit, MDChief of Infectious DiseasesDirector, Vaccine Education CenterChildren’s Hospital of Philadelphia,andProfessor of PediatricsUniversity of Pennsylvania School ofMedicine

The opinions expressed in this report donot necessarily reflect the views of the individuals or organizations.

3

Twenty percent of preschool children, aged 19-35 months,1 do not

receive all routine vaccinations to protect against a range of common

childhood diseases. While the Centers for Disease Control and Prevention

(CDC) announced a significant increase in vaccination rates from 2002 to

2003, each year an estimated 2.1 million preschool children are still not fully

immunized.2 Leaving a single child unprotected is one too many.

Preschoolers are particularly vulnerable to ahost of childhood diseases and therefore,are most in need of comprehensive, preven-tive vaccinations. However, this is the agegroup with the lowest immunization rates.The gap in rates is particularly concentratedin poor and minority communities.

From a variety of perspectives, including med-ical and financial, the public benefits when allchildren are vaccinated. High vaccinationrates are important safeguards against thespread of epidemics. Numerous cost-benefitanalyses show that vaccination against themost common childhood diseases deliverslarge returns on investment — saving $18.40in medical costs and indirect costs, such as dis-ability, for every $1 spent on immunization.3

In this report, Trust for America’s Health(TFAH) and Every Child By Two (ECBT):

1. Discuss the importance of childhoodimmunizations,

2. Examine immunization rates,

3. Discuss factors contributing to the gap invaccination rates for pre-school children,and

4. Recommend improvements to U.S. vacci-nation policy.

Ensuring that all children have access to thefull series of immunizations in a timely man-ner is achievable. Closing the vaccinationgap should be high on our list of nationalhealth priorities.

CLOSING THE VACCINATION GAP:

A Shot in the Arm forChildhood ImmunizationPrograms

“THERE ARE ACTUAL,

ACHIEVABLE MEASURES

THAT COULD BE TAKEN TO

IMMEDIATELY IMPROVE

PRESCHOOLER IMMUNIZATION

RATES IN THE U.S.

PRESCHOOLERS ARE

PARTICULARLY VULNERABLE

TO A HOST OF CHILDHOOD

ILLNESSES. NO CHILD IN

AMERICA SHOULD HAVE TO

GET SICK FROM A VACCINE

PREVENTABLE DISEASE.

IT'S TIME FOR US TO

REDOUBLE EFFORTS TO

PROTECT THE 20 PERCENT

OF PRESCHOOLERS WHO ARE

ROUTINELY NOT BEING

IMMUNIZED ON TIME.”

– ROSALYNN CARTER, Former First Lady of theUnited States, Presidentand Cofounder of EveryChild By Two

4

The current, common measure of full immu-nization coverage is referred to as the4:3:1:3:3 standard. This is gauged by measur-ing the percentage of children between 19 and35 months of age who have received the fol-lowing battery of immunizations: four ormore doses of diphtheria-tetanus-pertussisvaccine (DTaP); three or more doses of inacti-vated polio vaccine (IPV); one or more dose ofmeasles, mumps, rubella vaccine (MMR); threeor more doses of Haemophilus influenzae type

B vaccine (Hib); and three or more doses ofHepatitis B vaccine (HepB).

The 4:3:1:3:3 standard has been tracked for fiveyears.4 In 1999, the national coverage rate was73.2 percent. After remaining relatively stablefor four years, the rate jumped from 74.8 per-cent in 2002 to 79.4 percent in 2003 (SeeChart).5 Although the 2003 coverage rate rep-resents an all- time high, 20 percent of childrenstill do not receive all needed vaccines on time.

HOW IMMUNIZATION COVERAGE IS MEASURED

YEARLY IMMUNIZATION RATE PERCENTAGE FOR THE 4:3:1:3:3 STANDARD

1999-20036

5

Although newborns receive antibodies fromtheir mothers and therefore enjoy short-termimmunity to many diseases, such immunityoften lasts only a month and generally expireswithin a year. Moreover, mothers pass noprotection to certain vaccine-preventable dis-eases, such as whooping cough.8

Thus, to prevent large segments of the popu-lation from disease exposure, vaccination mustoccur at an early age. It is particularly crucialto immunize young children since their bodiesare still developing, leaving them often inca-pable of fighting many diseases. Yet over 20percent of pre-school children do not receiveall needed vaccines, leaving them vulnerable tomany vaccine-preventable diseases, including:

Polio: Polio virus causes acute paralysis thatcan lead to permanent physical disability and

even death. Most permanent disabilities causedby polio occur in children.9

Measles: During recent measles outbreaks,half of the fatalities were in children underfive years of age.10

Diphtheria: Diphtheria results in death pri-marily in the very young and the elderly.11

Hepatitis B: Infants and children whobecome infected with hepatitis B virus are athighest risk of developing lifelong infection,which often leads to death from liver disease(cirrhosis) and liver cancer. Approximately 25percent of children who become infected withlife-long hepatitis B virus would be expected todie of related liver disease as adults.12

Mumps: Mumps is a major cause of deafnessin children.13

WHY ARE PRESCHOOL-AGED VACCINATIONS SO CRITICAL?

Importance ofChildhood Immunization

Over the course of the twentieth century and into the twenty-first, vaccines

have been developed to reduce the incidence of devastating vaccine-pre-

ventable diseases. Immunization policy in the U.S. currently focuses mainly on

children, as vaccine-preventable diseases can strike young children who are most

susceptible to their consequences. Laws requiring that children be immunized

prior to entering school, which were initiated among the states during the Carter

Administration, have pushed immunization coverage rates to near universal per-

centages among school-aged children (95 percent for school-aged children.)7

Immunization is one of the most success-ful public health achievements of the 20thCentury. Due to systematic programs,smallpox has been eliminated worldwide,and cases of polio, measles, pertussis,diphtheria, and Hib are at all-time lows.The burden of other diseases has been sig-nificantly reduced.

According to one study, the standard child-hood immunization series prevents approxi-mately 10.5 million cases of infectious illness ayear and 33,000 deaths in the United States.14

Another report published by the WorldHealth Organization, UNICEF and the WorldBank found that three million lives are savedworldwide each year through childhoodimmunizations — a number that could bedoubled with increased funding.15

6

Smallpox: Varying strains of smallpox diseasehave been identified, each extremely infec-tious and leading to skin lesions, permanentscarring, and serious illness. Depending on thestrain, fatality rates run as high as 25 percent toless than one percent.16 Smallpox is immu-nization’s greatest success story to date, as thisdreaded disease has been eradicated. As ofthe early twentieth century, tens of thousandsof smallpox cases were reported in the U.S.each year.17 The last case of smallpox in theU.S. was reported in 1949, and routine vacci-nation of American children ended in 1971.The last case of smallpox in the worldoccurred in Somalia in 1977.18 In 1980, scien-tists officially declared that vaccines had beensuccessful at eradicating smallpox worldwide.

Polio: Before polio vaccine was available, theU.S. had 50,000 polio cases a year, including13,000 to 20,000 cases of paralytic polio.These annual epidemics of polio often leftthousands of victims — mostly children —permanently in braces, crutches, wheel-chairs, and with iron lungs.19 Immunizationhas eliminated the disease in the U.S. andWestern Hemisphere, and the World HealthOrganization had set a goal of eradicatingpolio worldwide by the end of 2004.However, Nigeria’s northern State of Kanosuspended polio immunization in August2003 amid rumors that the vaccine was con-taminated with HIV and that it caused infertil-ity. Consequently, polio cases reemerged inNigeria and other previously polio-free coun-tries. Polio immunization has restarted inKano and the WHO now estimates that poliocan be eradicated by the end of 2005.20

Measles: Measles is one of the most infec-tious diseases in the world; more than 90 per-cent of people who are not vaccinated will getmeasles if they are exposed to the virus. Inthe U.S., roughly one in five who develop thedisease require hospitalization for one ormore complications.21 Before 1963, morethan three million cases of measles and 500deaths from measles were reported eachyear. More than 90 percent of children hadmeasles by age 15.22 Widespread introductionof vaccine has resulted in a reduction ofmeasles incidence from 894,134 cases in 1941to 89 cases in 1998 and 44 cases in 2002.23, 24

Pertussis: Pertussis (also known as whoop-ing cough) can be a severe illness, resulting inprolonged coughing spells that can last formany weeks or even months. In children, thedisease often leads to vomiting and can inter-fere with efforts to eat, drink, and breathe;children often suffer dehydration and lostweight, and infants are prone to pneumonia,brain damage, seizures, and mental retarda-tion.25 Before pertussis immunization wasavailable, nearly all children developedwhooping cough. The CDC reports that fol-lowing the introduction of immunization inthe mid-1940s, pertussis incidence declinedmore than 99 percent by 1970 and to an all-time low of 1,010 cases by 1976. However,since then, an increase in incidence of the dis-ease has been documented, with more than10,000 cases reported in 2003 and outbreaksoccurring every three to four years.Furthermore, some researchers have esti-mated that only one-third of pertussis casesin the U.S. are actually reported. 26

Diphtheria: Diphtheria is a serious bacterialdisease that frequently causes heart and nerveproblems. The death rate is five percent to 10percent, with higher death rates (up to 20percent) in the very young and the elderly. Inthe 1920s, prior to regular immunization,there were 100,000 to 200,000 Americancases of diphtheria each year and 13,000 peo-ple died from the disease.27 Since the intro-duction of immunization, diphtheria has dra-matically declined from a high of 206,939reported cases in 1921 to one in 2002. 28, 29

Haemophilus Influenzae type B (Hib):Before Hib vaccination, Haemophilus influen-zae type B caused serious infections in 20,000children each year, producing meningitis(12,000 cases) and pneumonia (7,500 cases),bacteria in the blood, and inflammation of theepiglottis.30 Hib meningitis killed 600 childreneach year, and left many survivors with deaf-ness, seizures, or mental retardation. Sinceintroduction of conjugate Hib vaccine inDecember 1987, the incidence of Hib hasdeclined by 98 percent.31 The number ofcases of serious Hib disease in children underfive years of age reported in 2002 was 331.32

IMMUNIZATION SUCCESSES THROUGH THE YEARS

7

Rubella: While rubella is usually mild in chil-dren and adults, up to 90 percent of infantsborn to mothers infected with rubella duringthe first trimester of pregnancy will developcongenital rubella syndrome (CRS), resultingin heart defects, cataracts, mental retarda-tion, and deafness. Expectant mothers arenow routinely tested for rubella antibodiesduring pregnancy. From 1964-1965, beforeroutine rubella immunization, there was anepidemic of 12.5 million cases that resulted inan estimated 20,000 infants born with CRS;2,100 neonatal deaths; and 11,250 miscar-riages. Of the 20,000 infants born with CRS,11,600 were deaf, 3,580 were blind, and1,800 has mental retardation. Due to thewidespread use of rubella vaccine, only 18cases of rubella and one case of CRS werereported in 2002.33

Hepatitis B: National studies show thatabout 12.5 million Americans have beeninfected with hepatitis B virus at some pointin their lifetime. Over 10 percent of theseindividuals develop chronic infection, increas-ing chances for chronic liver disease, cirrho-sis, and liver cancer. An estimated 20 to 30percent of such cases stem from infectionduring childhood. Approximately 5,000 peo-ple die each year from hepatitis B-relatedliver disease resulting from chronic hepatitisB. However, with the recent advent of vac-cine, the number of new infections per yearhas declined from an average of 450,000 inthe 1980s to 7,996 in 2002.34 The greatestdecline has occurred among children andadolescents due to routine hepatitis B vacci-nation.35

Tetanus: Tetanus, commonly known asLockjaw, is a severe disease that causes stiff-ness and spasms of the muscles and is oftenfatal. The larynx (throat) can close causingbreathing and eating difficulties, musclesspasms can cause fractures (breaks) of thespine and long bones. Some people go into acoma, and die. Approximately 30 percent ofreported cases end in death. From 1922-1926, there were an estimated 1,314 cases oftetanus per year in the U.S.36 In 2002, as aresult of extensive immunization, only 25cases of tetanus were reported.37

Mumps: While usually a mild disease, mumpscan produce swelling of the brain, nerves andspinal cord which in some cases leads to paral-ysis, seizures, and fluid in the brain.Moreover, in children, it is a major cause ofdeafness. Prior to immunization, the U.S. suf-fered approximately 200,000 cases per year.After vaccine licensure in 1967, reports ofmumps decreased rapidly, but brief resur-gences, such as an epidemic in 1987 that ledto a reported 12,848 cases occurred. Sincethen, a second dose of mumps vaccine wasadded to the standard childhood MMR seriesand as a result, annual cases are now in thehundreds rather than the thousands.38

Varicella: Although generally mild, varicella(chickenpox) virus can lead to severe illnesscausing complications such as secondary bacte-rial infections, severe loss of fluids (dehydra-tion), pneumonia, central nervous systemirregularities, and shingles. The virus is highlycontagious and thus virtually all unimmunizedindividuals contract varicella if exposed to thevirus, usually prior to adulthood. Before immu-nization, the U.S. reported an estimated fourmillion cases a year, leading to approximately11,000 hospitalizations and 100 deaths. A newchickenpox vaccine was licensed in 1995, andincidence of the disease is now declining.39

Chickenpox can be particularly dangerous toa developing fetus. Pregnant women whohave never had chickenpox are at risk of con-tracting chickenpox during pregnancy. A smallpercentage of women who get chickenpox inthe first or second trimester can have babieswith birth defects known as “congenital vari-cella syndrome.” In addition, chickenpox maybe more severe in pregnant women than inothers putting the woman at risk of severecomplications. Vaccinating close contacts of asusceptible pregnant woman is the mosteffective way to protect her from disease.40

Influenza: Influenza is a serious disease. Inan average year, the flu causes 36,000 deathsand 114,000 hospitalizations in the UnitedStates. While the majority of deaths resultingfrom flu occur in the elderly, rates of infectionare highest among children and hospitaliza-tion rates among children zero-to-one yearold are similar to those of the elderly.

8

In addition to saving lives and improving thequality of life, immunization generates signif-icant economic benefits. According to anextensive cost-benefit analysis by the CDC,every dollar spent on immunization saves$6.30 in direct medical costs, with an aggre-gate savings of $10.5 billion. When includingindirect costs to society — a measurement oflosses due to missed work, death and disabili-ty as well as direct medical costs — the CDCnotes that every dollar spent on immuniza-tion saves $18.40, producing societal aggre-gate savings of $42 billion.41 Various cost-ben-efit analyses produce similar measurements.42

The DTaP vaccine is particularly cost effec-tive. Each dollar spent on DTaP produces$8.50 of direct medical cost savings and $24of societal savings.43 More importantly, diph-theria immunizations alone prevent almost13,000 deaths per year.

Other vaccines also produce a positivecost-benefit outcome:

� Hib produces $1.40 in direct and $2 insocietal savings

� Hepatitis B produces $0.50 in direct savings in both infants and adolescents,$1.30 in direct prenatal savings, $2.20 insocietal savings in adolescents, $3.10 insocietal savings in infants, and $14.50 insocietal savings in prenatal cases

� Inactive polio vaccine produces $3.03 indirect and $5.45 in societal savings

� MMR produces $10.30 in direct savingsand $13.50 in societal savings for eachdollar spent

� Varicella produces $0.90 in direct and$5.40 in societal savings.44

BENEFITS OF IMMUNIZATIONS: ECONOMIC SAVINGS

Immunization protects not only the individ-ual receiving the vaccine, but the whole com-munity as well. By eliminating potential car-riers of disease, immunization can protecteven those who are not immunized becausetheir chances of encountering the diseaseare limited. This is referred to as “herdimmunity.” This is especially important forthose who cannot be immunized, including:

� Those who are too young to be vaccinated(e.g., children less than a year old who arenot yet vaccinated for measles virusbecause the mother’s antibodies, which

are transmitted to the newborn, may ren-der the vaccine ineffective. Because anti-body levels vary among infants, manyremain susceptible to measles virus priorto receiving the vaccine at age one);

� Those who cannot be vaccinated for med-ical reasons (e.g., children and adults withweakened immune systems); and

� Those for whom the vaccine proves inef-fective, meaning they do not develop anadequate response to vaccination.

BENEFITS OF IMMUNIZATION: “HERD IMMUNITY”

9

Ninety-five percent of school-aged childrenare fully covered as a result of laws mandat-ing immunization prior to school entry.46

These laws arose in the late 1970s and early1980s as part of a major, nationwide effortby the Carter Administration to bolster lowimmunization rates in children.47 By the2001-2002 school year, all 50 states, theDistrict of Columbia, and Puerto Rico hadadopted school entry requirements, cover-ing kindergarten through 12th grade andday care centers. In forty-eight states,Head Start programs adopted school entryrequirements. However, the exact require-ments for all these groups vary by state.48

Moreover, faith-based and home daycarecenters are not universally required toscreen for immunization, leaving this pop-ulation potentially vulnerable to diseaseoutbreaks.49

In contrast, 20 percent of preschool childrenare not fully immunized. CDC data indicatethat 79.4 percent of children between 19 and35 months of age received all vaccines rec-ommended for universal administration.50

Although this rate is an all-time high, thereare disparities among the states and citiesthat reveal a crack in the system designed toprotect young children from vaccine-pre-ventable diseases. The 15 percent gap incoverage rates between school-aged childrenand preschoolers is concerning, particularlysince toddlers are at a critical age develop-mentally when diseases hit hardest.51

Coverage rates vary significantly from stateto state, from a high of 94 percent inConnecticut to a low of 67.5 percent amongtoddlers in Colorado. Twenty-six states haveimmunization rates below 80 percent.52

(See Table on Page 10)

Immunization RatesWORKING TO SAVE KIDS

EARLY IN THE ADMINISTRATION, MRS. CARTER CALLED ME. SHE AND

THE PRESIDENT HAD DINED WITH SENATOR DALE BUMPERS AND HIS WIFE THE NIGHT

BEFORE. “BETTY HAS SOME IDEAS ABOUT IMMUNIZING CHILDREN AND I WOULD LIKE

FOR YOU TO SEE HER.” I CALLED MRS. BUMPERS THAT DAY AND SHE CAME TO MY

OFFICE ON FEBRUARY 18, 1977. SHE EXPLAINED HOW “WHEN DALE WAS GOVERNOR

OF ARKANSAS, WE ORGANIZED EVERYTHING FROM THE NATIONAL GUARD TO THE

CHURCHES AND SCHOOLS TO GET CHILDREN IMMUNIZED. IF YOU GET EVERYONE

GOING, IT WILL WORK,” SHE SAID. 45 AS A RESULT OF THIS MEETING A NATIONWIDE

EFFORT TO RAISE IMMUNIZATION RATES ENSUED.

— Joseph A. Califano, Jr., Former Secretary of Health, Education and Welfare

“

”

“THE CDC'S ANNOUNCE-

MENT OF THE HIGHEST

IMMUNIZATIONS RATES FOR

INFANTS AND TODDLERS IS

GREAT NEWS. THE EVEN

BETTER NEWS IS THAT WE

KNOW WHAT IT WOULD

TAKE TO REACH THE LAST

20 PERCENT OF

PRESCHOOLERS. HOPEFULLY,

THE LATEST PROGRESS WILL

REINVIGORATE ALL OF US

TO STRIVE FOR FULL

CHILDHOOD VACCINATION

RATES IN AMERICA.”

— BETTY BUMPERS, Former First Lady ofArkansas, Cofounder ofEvery Child By Two

10

4:3:1:3:3 Series

Alabama 80.4

Alaska 79.7

Arizona 76.9

Arkansas 76.5

California 77.4

Colorado 67.5

Connecticut 94.0

Delaware 76.3

District of Columbia 76.2

Florida 81.0

Georgia 76.6

Hawaii 82.0

Idaho 78.1

Illinois 82.9

Indiana 79.0

Iowa 81.1

Kansas 75.7

Kentucky 81.0

Louisiana 69.9

Maine 78.6

Maryland 81.3

Massachusetts 90.7

Michigan 81.5

Minnesota 83.9

Mississippi 83.6

Missouri 83.3

4:3:1:3:3 Series

Montana 80.0

Nebraska 80.4

Nevada 75.7

New Hampshire 86.5

New Jersey 75.0

New Mexico 75.2

New York 78.6

North Carolina 86.7

North Dakota 80.4

Ohio 82.3

Oklahoma 70.5

Oregon 76.5

Pennsylvania 86.2

Rhode Island 85.2

South Carolina 84.3

South Dakota 80.9

Tennessee 78.8

Texas 74.8

Utah 78.8

Vermont 83.6

Virginia 84.0

Washington 75.3

West Virginia 74.6

Wisconsin 81.2

Wyoming 75.8

US Average 79.4

4:3:1:3:3 Four or more doses of DTP, three or more doses of poliovirus vaccine, one or more doses of any MCV, three or more doses of Hib, and three or more doses of HepB

Source: CDC, U.S. National Immunization Survey, 2003

Estimated Vaccination Coverage Rate for Children 19-35 Months of Age by State

11

Some urban settings have significantly lowimmunization rates. According to CDC datacollected for a select group of cities andcounties, Houston, Texas reports the lowestimmunization coverage rate at 69.2 percent.Detroit is close behind with a rate of 69.6percent. The immunization rate is muchhigher in Boston, 88.8 percent and SantaClara County, California, 83.6 percent.∂

(See Table)

Certain groups also suffer disproportionatelylow rates of coverage. Immunization rates forthe African-American community are the lowest according to CDC figures. For whitechildren, the immunization rate is 82.5 per-cent, while for African-American children, itis 73 percent.54 Many experts believe thatrates in the African-American community

may actually be far lower than official num-bers.55 However, significant progress has beenmade; for example, in 1970 African-Americanand minority children had measles immu-nization rates 20 percent lower than whitechildren.56 Among all races, underimmuniza-tion is generally concentrated among theimpoverished.57

Vaccinations in Urban Areas and Among Minority Communities

About 2.1 million children are left unpro-tected every year, leading to outbreaks ofdisease. For example, from 1989-1991, ameasles epidemic resulted in 55,000 report-ed cases, 11,000 hospitalizations, and 123deaths; this afflicted primarily preschoolchildren in low income inner city neighbor-hoods.58 The resurgence was attributed tolow immunization rates, inadequate accessto care, missed opportunities to administervaccines, and inaccurately high estimates ofprotection on the part of parents andproviders.59 Research showed that the epi-demic was spawned primarily by communi-ties in which only 50 percent of preschool-aged children had received the vaccine.60

In 2003, more than 10,000 pertussis cases werereported. More recently, parts of the Midwesthave been experiencing pertussis outbreaksthis year. As of mid-July 2004, Wisconsinreported more than 800 cases of pertussis.61

The city of Chicago has experienced 107 con-firmed cases of the disease as of early July.62

These resurgences have been occurring more

frequently in recent years throughout thecountry, and some researchers have estimatedthat only one-third of pertussis cases in theU.S. are actually reported.

Influenza is another virus that results in signif-icant disease burden each year. Influenza(flu) is a serious disease, and people of all agescan get infected. In an average year, the flucauses 36,000 deaths and 114,000 hospitaliza-tions in the United States. While the majorityof deaths resulting from flu occur in the eld-erly, rates of infection and hospitalization ratesare highest among children. During the 2003-2004 flu season, over 150 children died frominfluenza and many more were hospitalized asa result of complications. At its October 2003meeting, the Advisory Committee onImmunizations Practices (ACIP) voted toexpand its influenza recommendation toinclude annual vaccination of all children 6-23months of age. The ACIP also recommendsthat close contacts of children 0-23 months ofage be vaccinated annually against influenza.

Disease Outbreaks

City/County Immunization Coverage Rate

(Percent)

Highest Rates

Boston 88.8

Santa Clara County, CA 83.6

Franklin County, OH 81.8

Lowest Rates

Dallas 70.2

Detroit 69.6

Houston 69.2

Source: CDC, U.S. National Immunization Survey, 2003

12

Each year the Advisory Committee on Immunization Practices (ACIP) meets to discuss additionsand edits to the recommended childhood and adolescent immunization schedule. The scheduleis then approved by ACIP, the American Academy of Pediatrics (AAP), and the AmericanAcademy of Family Physicians (AAFP).

RECOMMENDED COVERAGE

13

Several factors are contributing to the fact that 20 percent of American

preschoolers are not receiving all needed immunizations. These fac-

tors can be broadly described as:

� Systemic issues including underfunded immunization programs

� Underutilized and unevenly supported immunization registry systems among the states

� Public misperception about the importance of timely vaccination and vaccine safety

Factors Contributing to the20% Vaccination Gap

Efforts to immunize children involve a set ofcomplex and separate financial arrangementsamong federal, state, and local health agencies,as well as collaborations with public and privatehealth care providers. State governments havethe responsibility for meeting the health needsof residents who are not served or are under-served by the private health care sector. Eachstate invests in immunization programs, but nostate has sufficient resources to ensure all chil-dren are immunized. The federal governmentthus assists states by providing funds for vaccinepurchase and infrastructure support.63

Federal assistance is provided primarilythrough two sources: Section 317 of thePublic Health Service Act, administered bythe National Immunization Program withinthe CDC, and the Vaccines for Children(VFC) program, administered jointly by theCDC and the Centers for Medicare andMedicaid Services (CMS).64, 65 The Section317 program provides funds for state immu-nization operational costs and many of thevaccines provided in public health clinics.The VFC program aims to improve vaccineavailability to children nationwide by provid-ing vaccines free-of-charge to Medicaid-eligi-ble, uninsured, underinsured, AmericanIndian, or Alaska Native children throughboth public and private providers. 66 In FY2004, funding for Section 317 grants was $418million and $1.2 billion for VFC.

Vaccine Delivery. Over half of immuniza-tions are paid for by the government,67 butabout 70 percent of vaccines are adminis-tered in private settings.68 The VFC pro-gram and the Medicaid program providepublicly-funded vaccines primarily throughprivate delivery.69 Alarmingly, the IOM hasfound that the private contribution to thispartnership may be weakening.70

Most public and private health insuranceincludes vaccine benefits, but the scope ofthese benefits varies widely by insurancetype and by vaccine. To address this issue,state and federal governments haverequired certain types of insurance coveragefor some vaccines. However, the regulatoryeffort is uneven and difficult to administer.71

Of growing concern is the plight of underin-sured children — those whose families havehealth care insurance that excludes vaccinecoverage, or that charges high deductibles orcopayments. These children, largely fromworking families, are not eligible to receivefederally-funded VFC vaccines unless theytravel to a Federally Qualified Health Center(FQHC), federally-designed comprehensivehealth organizations serving predominantlyunderserved population. Relying on FQHClimits access to many underserved childrendue to location or accessibility. Underinsuredchildren are not permitted to receive vaccines

Systemic Issues

14

at a public health clinic, even if they visit thatclinic for all of their other medical needs.Legislation, the Children’s Vaccine Access Actof 2004, has been introduced in Congress toremedy this, but has not been passed.

Requirements under the VFC program alsoaffect financing for some vaccines. The VFCstatute sets a limit, or cap, on prices that thefederal government pays for certain vaccines(e.g. tetanus and diphtheria (Td) vaccine)that were in use prior to 1993. The price capsare so low, however, that these vaccines wereremoved from the VFC program in 1998when no vendor would bid on a contract tosell the vaccines to the federal government.Consequently, these vaccines are unavailablefor purchase under the program.

Vaccine Supply. Closely related to vaccinefinancing and delivery is supply. The vac-cine supply system has experienced majorchanges in recent decades and many believethat the current system may be in jeopardy.In the last 30 years, over 25 companies pro-duced vaccines. However, currently only fivecompanies produce all vaccines recom-mended for routine use by children (andadults).72 Although vaccines are importantdisease prevention tools and have significantsocietal value, they often generate lower rev-enues than pharmaceuticals. Vaccines mustcompete with other more lucrative productsin a manufacturer’s portfolio.73

In addition, the process of developing andmanufacturing vaccines is complex, expen-sive, and lengthy. Research and developmentcan take more than five years and there is along lead time for manufacturing a single lotof vaccines up to a year. In addition, the U.S.

Food and Drug Administration’s (FDA)process for reviewing vaccines is more com-plex than for pharmaceuticals. Moreover,vaccine manufacturing is more uncertainthan most other pharmaceutical products.For example, the composition of the influen-za virus vaccines changes nearly every year.74

Vaccine supply has also been plagued byrecent shortages that were unprecedented inscope and severity. While temporary produc-tion problems appear to have eased, thepotential for disruption remains.75

Shortages, such as the one during 2001-2002for DTaP, MMR, varicella, and pneumococcalconjugate vaccines can lead to deferral inimmunization. Reasons for the recent short-ages include one vaccine manufacturer’sdecision to cease production of DTaP andmanufacturing problems at production facil-ities. In addition, an unexpectedly rapiduptake/demand for the new pneumococcalconjugate vaccine was accompanied by spo-radic manufacturing problems. Changes inrecommendations regarding vaccines,including the decision to eliminate the use ofthimerosal as a preservative and an expand-ed age recommendation for flu vaccineamong adults, also led to vaccine shortages.

More recent vaccine supply issues have alsooccurred -- a shortage of influenza vaccineduring 2003-2004. The severe start to theflu season, and the deaths of five young chil-dren in Colorado spurred public demandfor vaccine and shortages in some parts ofthe U.S. ensued. In addition, shortages ofpneumococcal conjugate vaccine in early2004 developed due to production prob-lems of the sole manufacturer.

15

Between 1999 and 2003, the cost to immunizeone child rose from $186 to $472 per child, asnew vaccines have been added to the recom-mended schedule. Moreover, the cost of vac-cines is projected to rise substantially over thenext several years. The current cost of the rec-ommended vaccine series for children throughage six is estimated to rise as high as $1,200 perchild by 2020, due in large part to the develop-ment of new, more expensive vaccines.76

The projected three-fold increase in immu-nization costs coincides with substantial

pressure on federal and state budgets.Currently, approximately 56 percent ofchildhood vaccine is purchased with publicdollars, including federal, state and localfunds; the remaining vaccine is purchasedin the private sector.77

Federal appropriations have not kept pacewith the cost of vaccines. As the chart shows,the cost of immunizing one child was esti-mated at $472 in 2004. However, the feder-al appropriation for the immunization of achild is only $220, far short of the total cost.

States have reduced funding for immuniza-tions, while at the same time vaccine costscontinue to rise. The Institute of Medicine(IOM) found that in response to state budgetcuts, most reduced the scale of effort of theirimmunization activities, commonly reducingoutreach, education efforts, and vaccinedelivery arrangements with contractors. Halfof the states have reported that budget cutsaffected staffing, requiring them to reduceimmunization program personnel, consoli-date positions, or leave vacancies unfilled.78

IOM’s “Calling The Shots” report states that,“immunization financing was explicitly struc-

tured to be a federal-state partnership...feder-al policymakers never expected federal fundsto be sufficient to cover the full cost of vaccinepurchase and delivery for disadvantagedgroups... and federal funds are provided tosupplement, not supplant, state investments inimmunization programs.” Various opinionsregarding state versus federal roles in the pur-chase of vaccines exist among the vaccineadvocacy community. However, all clearlyagree that decreased state investments pairedwith insufficient federal funding must beremedied in order to insure an equitable dis-tribution of vaccines among all U.S. children.

Inadequate Immunization Program Funding and Vaccine Cost Increases.

Cost of Vaccines to Immunize One Child vs. Annual Federal VaccinePurchase Appropriations

Source: Association of State and Territorial Health Officers

16

Immunization Information Systems, alsoknown as immunization registries, are confi-dential, computerized information systemsthat collect vaccination data about childrenwithin a geographic area.79 Children aretypically entered into a registry at birth(often through a linkage with electronicbirth records) or at first contact with thehealth care system (parents may declinesuch participation). A registry can providea single source for all community immu-nization data, if a registry includes all chil-dren in a given geographic area and allproviders follow through with reporting ofimmunization information.

Registries allow health care providers to con-sult a unified immunization record. Withsuch records, health care providers mayensure that a child’s immunizations are up-to-date, send reminders when immunizationis due or missed, and prevent duplicativeimmunization. In addition, the registriescan identify high risk, under-immunizedpopulations, thus helping to prevent diseaseoutbreaks while focusing public health out-reach dollars in areas of most need. Vaccinedistribution is streamlined, and communityand state coverage rates can be tracked forpublic health purposes. Registries can alsohelp providers better track the immuniza-tions they provide, resulting in more accu-rate (often increased) reimbursement fromparticipating health plans.

Approximately 11,000 children are born inthe U.S. every day, each in need of the fullseries of immunizations by age two.Frequent changes to the immunizationschedule due to the advent of new and/ornewly combined vaccines results in confu-sion among both the provider communityand parents. Keeping track of immuniza-tions through registries helps alleviate thisconfusion, resulting in more efficient, time-ly, and cost-effective vaccination. For exam-ple, 21 percent of 19-35 month olds receive

at least one extra dose of unneeded vaccineat a total cost of $15 million. In addition,22 percent of American children see two ormore providers in their first year of life andthree percent visit three or more providers.80

Each change in providers necessitates amanual record pull and review at a totalannual cost of approximately $16 million.81

Every state has either a functioning registry,or a registry under development. Severalstates have more than one registry with plansto connect systems in the future. An estimat-ed $300 million under the federal immuniza-tion grant program (section 317 of the PublicHealth Services Act) has been awarded insupport of registries since 1994. While manyregistries are partially supported via state andprivate funds (including significant fundingfrom the Robert Wood Johnson Foundation),the source of the majority of funds utilized todevelop and maintain registries has been thefederal government through the immuniza-tion grant program. Since these funds are dis-cretionary (subject to the annual federalbudget process) and since state grantees haveautonomy in determining how to use allocat-ed infrastructure funding, registries through-out the country are at different stages indevelopment and recruitment of providers.

Nationwide, only an estimated 43 percent ofchildren under age six have one or more oftheir immunizations recorded in a registry.Approximately 75 percent of publicproviders are using the registries, but only31 percent of the private providers partici-pate.82 Although in the long run registriescan save immunization programs, providers,schools, and other stakeholders significantfunds, recruitment to the private providercommunity and connections to schoolsrequire outreach dollars. Unfortunately,immunization programs faced with level ordecreased funding often place registries atthe bottom of their list of funding priorities.

Immunization Information Systems (Registries)

17

A major concern of many public health offi-cials is that immunization may be taken forgranted. Studies show that recipients oftenundervalue vaccines and that both parentsand physicians often do not recall thescourges once caused by now vaccine-pre-ventable diseases. Moreover, there havebeen media reports sensationalizingunfounded allegations regarding vaccinesafety. In addition, numerous Web sites,alternative medicine practitioners, anti-vac-cine advocates and several public officialsthat dispute the safety of various vaccineshave caused public alarm. Various rumorsand theories, many without merit, also havefrightened some away from immunization.83

Parents’ views about vaccination can rangefrom absolute support to outright objection.A poll of pediatricians and family physiciansfound that three out of four have encoun-tered a parent that refused child vaccinationduring the previous year.84 Many of thosewho refuse immunization are misinformedand/or poorly educated about vaccines andtheir side-effects. One major national sur-vey found that one in four parents mistak-enly believes that too many vaccines canweaken a child’s immune system.85

According to a recent study, “attitudes,beliefs, and behaviors indicative of vaccinesafety concerns contribute substantially tounderimmunization in the United States.”Study researchers concluded that childrenfrom non-Hispanic white, higher-incomefamilies who were under-immunized withtwo or more vaccines missed these essentialvaccinations because their parents haverefused to immunize them out of fear overvaccine safety and mistrust of their doctors.Although the study found that vaccine safe-

ty concerns were significantly more com-mon among parents of underimmunizedchildren, many parents of fully immunizedchildren had similar attitudes and beliefs.This should be of great concern because itmay result in drop in the high childhoodvaccination levels that the U.S. is currentlyexperiencing.86

The Institute of Medicine’s (IOM)Immunization Safety Review (ISR)Committee released its final report in May2004 examining the hypothesis that vaccines,specifically the measles-mumps-rubella(MMR) vaccine and thimerosal-containingvaccines, are causally associated with autism.Following a thorough review of the availableresearch on this subject, the committee con-cluded that, “the body of epidemiological evi-dence favors a rejection of a causal relation-ship between the MMR vaccine andautism...and that the body of epidemiologicalevidence favors a rejection of a causal rela-tionship between thimerosal-containing vac-cines and autism.” The committee also rec-ommended that funding for autism researchbe redirected towards efforts that will resultin more promising outcomes.87

In fact, vaccines are very safe. While minorside-effects from vaccines may develop, seri-ous adverse events are extremely rare andsome are so rare that risk cannot be accu-rately assessed. Most vaccine adverse eventsare minor and temporary, such as a sore armor mild fever and can often be controlled bytaking acetaminophen before or after vacci-nation. There are so few vaccine-relateddeaths that it is impossible to assess the riskstatistically; the Institute of Medicine in its1994 report states that the risk of death fromvaccines is “extraordinarily low.”88

Public Misperceptions

18

In 2003 the Institute of Medicine’s (IOM)Committee on the Evaluation of VaccinePurchase Financing in the U.S. issued areport, Financing Vaccines in the 21stCentury: Assuring Access and Availability. TheCommittee determined that the federal gov-ernment should pay for immunizations thatmeet a standard of societal benefit. It con-cluded that the current public-private financ-ing of both childhood and adult immuniza-tions is fragmented, unequal, and inadequate.Members of the Committee believe that thepresent system requires that providers trackpatient eligibility for too many federal pro-grams and insurance plans, forcing them torefer patients outside their practice and there-fore causing too many missed immunizations.The IOM recommended a far-reaching planto modernize the vaccine supply and deliverysystem in the U.S. The plan involved an insur-ance mandate, combined with a governmentsubsidy and voucher plan for the uninsured toreceive recommended vaccines.

The vaccine insurance mandate wouldrequire all private and public health plans,including Medicare, Medicaid, and the StateChildren’s Health Insurance Program, tocover all vaccines recommended by theAdvisory Committee on ImmunizationPractices. To fund the cost of vaccines andadministration fees, the IOM proposed a newfederal subsidy. To ensure delivery of all rec-ommended vaccines to the uninsured, theplan includes a government voucher. Thevalue of the voucher would be based on the

subsidy amount and could be used to obtainvaccines from the provider of choice.

Stakeholders, who recently met to provideformal feedback regarding the findings of thereport, clearly concurred with many of theconclusions which spurred the IOM’s recom-mendations including:

� The importance of vaccines for both chil-dren and adults and the need to increasevaccination coverage rates of adults;

� Vaccines are undervalued by society as awhole;

� There is an urgent need to assure access tovaccines and eliminate financial barriers;

� There must be adequate reimbursementof vaccines and administration costs toproviders;

� Regulatory harmonization is of para-mount importance; and

� Liability protection must be strengthenedto insure manufacturing stability.

However, none of the stakeholders seemed tofeel that the extensive changes recommendedby the IOM were either necessary or feasible.

TFAH and Every Child By Two recommendseveral immediate steps that should be takento improve immunization coverage rates andstabilize our nation’s vaccine production anddelivery system. The following four alterna-tive strategies would address many of the con-cerns brought to light by the IOM committee.

Recommendations:Improving ImmunizationCoverage

19

If the nation is to meet our Healthy People2010 goals of vaccinating 90 percent of chil-dren and adults, adequate funding resourcesmust be provided to the CDC, states, andlocalities to ensure that those in need ofimmunizations receive them. Therefore,TFAH and Every Child by Two support a FY2005 appropriation for the CDC’s NationalImmunization Program (NIP) of $824 mil-lion. This is a $180 million increase abovecurrent appropriations level. The $824 mil-lion includes $298 million for the Section 317Grants for vaccine purchases for children, $68million for the State Grants for vaccine pur-chase for adults, $228 million for State Grantsfor operations and infrastructure activities,including immunization registries, $79 mil-lion for the NIP prevention, safety, andadministrative activities, and $151 million forGlobal Immunization Activities.

Although immunization registries are oftenconsidered a lower budget priority as statesstrive to purchase and administer vaccines,they are one of the most effective tools avail-able today to improve immunization rates.Creating a fully operational system of immu-nization registries in each state could helpincrease the vaccination rate by identifyingthe remaining 20 percent of preschool-agedchildren who need vaccines, allowing pro-gram staff to pinpoint valuable outreachdollars. Approximately $50 million annual-ly is now being spent on registries, from amyriad of sources including federal grants,

state funding, and charitable donations.

The cost of immunization registries is esti-mated at $124 million annually, according tothe CDC. Despite that price tag, registriescould save over $270 million annually byavoiding various costs, such as manuallypulling medical records in provider offices forschool or daycare entry, duplicative vaccina-tions, and school system review of immuniza-tion records.89 By facilitating more efficientprogram functions such as vaccine adminis-tration and distribution, registries have thepotential of saving even more public funds.

The importance of registries led the NationalVaccine Advisory Committee (NVAC) tolaunch the Initiative on Immunization reg-istries in 1998 to facilitate development of anationwide network of community- and state-based immunization registries.90 NVAC hasnoted that, “the barriers to creating a nationalsystem of state-based registries are mainlypolitical and financial rather than technical.”91

Despite the benefits of fully operational reg-istries, health departments and political lead-ers often have difficulty prioritizing the alloca-tion of funds for the development and main-tenance of these systems because many relatedbenefits will be incurred mainly in the future.Support among state policymakers and healthagencies is critical to insure the completionand ongoing usage of these critical publichealth tools which have the potential of inter-acting with future electronic medical records.

Bi-partisan legislation has been introducedin Congress to improve the VFC program inseveral ways. Two key provisions increaseaccess to immunization for underinsuredchildren and eliminate the price caps oncertain vaccines that the federal govern-ment purchases from manufacturers. TheChildren’s Vaccine Access Act would permitunderinsured children to receive immuniza-tions at public health clinics, not justFederally Qualified Health Centers

(FQHCs). This would greatly increase thenumber of settings underinsured childrencould go to receive vaccines.

Another important provision of the bill isthe elimination of the price cap on certainvaccines that were in use prior to 1993 whenthe VFC statute was enacted. The price capshave resulted in certain manufacturers ofTd vaccines containing tetanus and diph-theria toxiods to refuse to bid on CDC pur-

1) Increased Funding for Vaccines and Vaccine Infrastructure Activities

2) Changes to Vaccines for Children (VFC) and State Children’s Health InsurancePrograms (SCHIP)

“NEGLECTING TO

VACCINATE 2.1 MILLION

PRESCHOOL KIDS ON TIME

EACH YEAR IS SIMPLY UNAC-

CEPTABLE. THIS IS NOT A

LOST CAUSE. WE COULD

MAKE REAL CHANGE, REAL

FAST BY TAKING SOME REAL

SIMPLE STEPS.”

– SHELLEY A. HEARNE, DRPH,Executive Director of Trust for America’s Health

20

TFAH and Every Child By Two supportefforts to require all health plans to fullycover ACIP-recommended immunizationswithout copayments and deductibles. Manyvaccines have tremendous societal benefit— they prevent disease and save lives. Inaddition, the economic savings areirrefutable. Requiring health plans to fullycover ACIP-recommended vaccines wouldeliminate the financial barriers faced by the

underinsured, working families of thisnation who consistently fall through thecracks of our healthcare system. The IOMrecommended such a mandate. However,TFAH and Every Child By Two recommenda stakeholder conference be convened tobuild consensus toward an appropriate andworkable financing mechanism, as manystakeholders disagreed with the IOM’s pro-posal for funding the mandate.

chase contracts. Consequently, these vac-cines are not available under VFC.

The Bush Administration supports these twomeasures, and included similar provisions itsFY 2005 budget proposal for the CDC.Congress should enact these important meas-ures to increase immunization access for theuninsured and to enhance vaccine supply.

In addition, children currently served by theState Children’s Health Insurance Programs(SCHIP) within states that designed theirSCHIP programs separate from Medicaid --

“non-Medicaid expansion SCHIPs” -- do notqualify for VFC vaccine, which is entitled toMedicaid children. Modifications to the pro-gram to make all children insured underSCHIP eligible for VFC have been presentedmany times. Bi-partisan legislation was intro-duced in 2001 in to address this issue. The leg-islation has been reintroduced in the 108thCongress as part of a larger bill, the HispanicHealth Improvement Act of 2003. TFAH andEvery Child by Two strongly support the pro-vision to permit all children under SCHIP toqualify for VFC vaccine.

3) Vaccine Insurance Mandate

To combat misperceptions about vaccinesand improve communication betweenproviders and parents, education and aware-ness efforts must be explored. A systematiceducational effort addressing common mis-conceptions is needed to ensure informeddecision making about immunizations.92

Health care providers including physicians,nurses, and other primary care practitionershave a unique opportunity to educate par-ents because parents see them as the mostimportant source of information aboutimmunizations.

The CDC has run a nationwide media cam-paign for the past seven years to reach par-ents and educate them about the impor-tance of immunizations.93 Despite the cam-paign, however, 20 percent of preschoolerscontinue to miss at least one recommendedvaccine. The CDC should continue to workclosely with primary care providers organi-

zations, such as the American Academy ofPediatrics, the American Academy of FamilyPhysicians, the National Association ofPediatric Nurse Practitioners and otherproviders to increase awareness among par-ents and legal guardians about the impor-tance of immunization and to develop mate-rials to debunk unfounded allegationsregarding the safety of vaccines. In addi-tion, primary care providers should beencouraged to utilize all child health careencounters, including wellness and acutecare visits, to screen and, when indicated,immunize children.

Finally, respected community leadersshould be encouraged to vocally supportimmunization activities while refutingunfounded claims about vaccine safety.The public should be encouraged to basetheir medical decisions on science, not anti-vaccine rhetoric.

4) Education and Awareness Measures

21

One outreach program that has been helpingto improve immunization rates among Latinosin the Los Angeles County area is “RescatandoSalud.” This project between the Los AngelesCounty Immunization Program, the EsperanzaCommunity Housing Corporation, and the St.John’s Family Childcare Center trains localwomen as community health promoters (orpromotoras) who conduct home visits.

Rescatando Salud serves a community that islargely Latino and is considered a pocket of needbased on its population size, lack of medical

services, low-income levels, low immunizationcoverage rates, and the high measles morbiditythat occurred during the 1990 measles outbreak.Promotoras educate approximately 350 Latinoparents a month through home visits. Data gath-ered from the Young Child Immunization Surveyin August 2000 show that immunization rates andhealth knowledge within the local communityhave increased significantly since the start ofRescatando Salud. The program has been so suc-cessful that it is currently being replicated in theLos Angeles African-American community.

C A S E S T U DY: PROJECT RESCATANDO SALUD

According to 2003 CDC data, Colorado hasthe lowest immunization coverage rate of anystate. Only 67.5 percent of 19 to 35 month oldchildren are fully vaccinated. The national aver-age is much higher — 79.4 percent. Despitethe low rate, Colorado experienced a signifi-cant jump in immunization rates from the 2002level of 62.7 percent. The state attributes thegain to aggressive efforts to obtain and provideadditional financial resources for immunization.

Given the state’s low immunization rate com-pared to the rest of the nation, the DenverPost examined immunization delivery in thestate.94 The analysis found the following fac-tors affected vaccination coverage rates:

Registries: Unlike many others, Colorado hasno statewide registry system to track the immu-nization history of each member of the state.Immunization advocates identify registries ascritical in a society in which families move,change jobs, change health insurance, andbecome uninsured with great frequency.Statistics within the state provide evidence of theeffectiveness of registries. For example, DenverHealth and Kaiser Permanente each have sys-tems, and significantly outperform the state interms of immunization coverage rates.95

Shortages: National vaccine shortages wereparticularly acute in Colorado, especially theFour Corners region, and the state is still catch-ing up, according to the Colorado Children’sImmunization Coalition.96

Funding: While the Vaccines for Children pro-gram provides federal assistance, state contribu-tions to the program dropped from $500,000 tozero in 2002.97 Colorado has since taken severalsteps to increase funding and improve immuniza-tion rates. For example, in January 2004, the statehealth director ordered that $388,355 in federalgrant funds be redirected to provide immunizationprogram enhancements for 15 local health agen-cies across Colorado. Governor Bill Owens ear-marked $500,000 in one-time federal funds toimmunization. These funds were part of themoney the state received under the Jobs andGrowth Tax Relief Reconciliation Act of 2003. TheColorado legislature has also restored $500,000 instate funding to the Immunization Program.98

Systemic Issues: An August 2004 study sug-gests that state Medicaid eligibility, administrative,and reimbursement policies have contributed todecreased access to needed services for chil-dren, including immunizations.99 The lack ofaccess may be one reason why Medicaid patientshave a significantly higher rate of certain illnessesin Colorado, including vaccine-preventable dis-eases. In addition, the state’s comparatively lowrates of physician reimbursement for Medicaidpatients mean fewer doctors accept the healthinsurance for the very poor, which leads to manychildren lacking a “medical home.”100

Public Perception: While the state has rough-ly the same average number of parents object-ing to immunization as other states, certain geo-graphic areas have extremely vocal parents thatdo not want their children immunized.

C A S E S T U DY: COLORADO

Appendix: Case Studies

22

Another case study shows how a targetedcommunity-wide effort can greatly improvepediatric immunization rates. During a recentNational Immunization Conference sponsoredby the CDC, Dr. Peter G. Szilagyi, Professor ofPediatrics at the University of Rochester,described how Rochester, New York turnedits immunization rates around, reducing andperhaps eliminating racial and socioeconomicdisparities within the community.

In 1993, the immunization rate for Rochester’slarge, impoverished and primarily African-American and Latino inner-city population wasmeasured at 55 percent, which compared to73 percent in the suburbs. A concerted effortat improvement succeeded dramatically. By1999, the same population had an immuniza-tion rate of 84 percent -- well above thenational average and 10 percent greater thanthe rest of New York state even after exclud-ing New York City.

The program for improvement began in 1993with a randomized, controlled trial by the

University of Rochester designed to establishwhether a reminder-recall-outreach interven-tion based in primary care offices could raiseimmunization rates. The pediatricians whocared for the greatest numbers of urban chil-dren were enlisted and asked to track vacci-nations and place reminder phone calls to par-ents who fell behind schedule. Home vacci-nation visits were conducted for the childrenfurthest behind. The results were extremelyimpressive and also provided increased com-pliance with other preventive services, such aslead and anemia screening.

As a follow-up, the local health department andthen the hospitals and insurers took responsibil-ity for costs and greatly expanded the project.By 1999, the program closed the urban-subur-ban gap from the 18 percent differential in 1993to a mere four percent. Moreover, the gapbetween whites and Latinos fell from 15 per-cent to one percent, and gap between whitesand African-Americans fell from 13 percent toseven percent.

C A S E S T U DY: ROCHESTER, NEW YORK

23

Endnotes1 The term preschool children in this paper

refers to children 19 to 35 months old.

2 Philip J. Smith, Susan Y Chu, Lawrence E.Barker, “Children Who Have Received NoVaccines: Who Are They and Where Do TheyLive?” Pediatrics: 114.1 (2004).

3 Ross Rapoport, “CDC: Immunizations HighBut Shot In Arm Still Needed,” Cox NewsService. 1 August 2003.

4 CDC had previously collected data on the 4:3:1:3immunization series, which does not include theHaemophilus influenzae type B (Hib) vaccine.

5 “National, State, and Urban Area VaccinationCoverage Among Children Aged 19-35 Months— United States, 2003.” Morbidity and MortalityWeekly Report: 53 (30 July 2004): 658-661.

6 Ibid.

7 Immunization rates cited are for the 4:3:1:3:3standard. This is gauged by measuring the per-centage of children who have received the fol-lowing immunizations: four or more doses ofdiphtheria-tetanus-pertussis vaccine (DTaP);three or more doses of polio virus vaccine; oneor more dose of measles-containing vaccine(MCV); three or more doses of Haemophilusinfluenzae type B (Hib) vaccine; and three ormore doses of Hepatitis B vaccine.

8 “The Importance of Childhood Immunizations,”Centers for Disease Control and Prevention.<http://www.cdc.gov/nip/publications/fs/gen/importance.htm> 8 July 2004.

9 “What Would Happen If We StoppedVaccinations,” Centers for Disease Control andPrevention. <http://www.cdc.gov/nip/publi-cations/fs/gen/WhatIfStop.htm> 9 July 2004.

10 W. Atkinson, C. Wolfe, S. Humiston, R. Nelson,eds. Epidemiology and Prevention of Vaccine-Preventable Diseases, 6th ed. (Atlanta: Centersfor Disease Control and Prevention, 2000).

11 Ibid.


13 Ibid.

14 Zhou, et al, “Economic Evaluation of RoutineChildhood Immunization with DTaP, Hib, IPV,MMR and Hep B Vaccines in the UnitedStates,” Pediatric Academic SocietiesConference, Seattle, Washington, May 2003.

15 Randy Trick, “More Money Urged to ImproveChild Immunization Rates,” Los AngelesTimes, 22 November 2002: 22.

16 F. Fenner, D.A. Henderson, et al., “Smallpox andIts Eradication,” (Washington, D.C.: WorldHealth Organization Press, 1988) 4-5.<http://www.who.int/emc/diseases/small-pox/Smallpoxeradication.html> 4 August 2004.

17 Impact of Vaccines Universally Recommendedfor Children. (Atlanta: Centers for DiseaseControl and Prevention, 2 April 1999)<http://www.cdc.gov/od/oc/media/fact/impvacc.htm> 16 July 2004.

18 “Notice to Readers: 25th Anniversary of theLast Case of Naturally Acquired Smallpox,”Morbidity and Mortality Weekly Report: 42(25 October 2002): 952.


20 Lisa Schlein, “Nigeria: WHO Claims GlobalPolio Eradication Back on Track.” Voice ofAmerica News, <http://www.voanews.com/arti-cle.cfm?objectID=A71A3589- 4F99-489E-A325EC32D9E87919> 3 August 2004.


22 W. Atkinson, C. Wolfe, S. Humiston, R. Nelson,eds. Epidemiology and Prevention of Vaccine-Preventable Diseases, 6th ed. (Atlanta: Centersfor Disease Control and Prevention, 2000).

23 Ibid.

24 “Summary of Notifiable Diseases - UnitedStates, 2002” Morbidity and Mortality WeeklyReport: 53 (2004): 16-17.

25 “What Would Happen If We StoppedVaccinations,” Centers for Disease Control andPrevention. 9 July 2004 <http://www.cdc.gov/nip/publications/fs/gen/WhatIfStop.htm>.

26 Pertussis Outbreak Digest 2003.<http://www.pertussis.com/digest/index.html.> 18 August 2004.

27 W. Atkinson, C. Wolfe, S. Humiston, R.Nelson, eds. Epidemiology and Prevention ofVaccine-Preventable Diseases, 6th ed.(Atlanta: Centers for Disease Control andPrevention, 2000).

24

28 Ibid., and “What Would Happen If We StoppedVaccinations,” Centers for Disease Control andPrevention. <http://www.cdc.gov/nip/publi-cations/fs/gen/WhatIfStop.htm> 10 July 2004.

29 “Summary of Notifiable Diseases — UnitedStates, 2002” Morbidity and Mortality WeeklyReport: 53 (2004): 16-17.

30 K.M Bisgard, A. Kao, J. Leake J, et al.“Haemophilus influenzae invasive disease inthe United States, 1994-1995: Near disap-pearance of a vaccine-preventable childhooddisease,” Emerging Infectious Diseases: 4(1999): 229-237.

31 “Progress Toward Eliminating Haemophilusinfluenzae Type B Disease Among Infantsand Children — United States, 1987-1997,”Morbidity and Mortality Weekly Report: 47(1998): 993-998.

32 “Summary of Notifiable Diseases — UnitedStates: 2002,” Morbidity and Mortality WeeklyReport: 53 (2004): 16-17.

33 Ibid.

34 Ibid.

35 “What Would Happen If We StoppedVaccinations,” Centers for Disease Controland Prevention. 9 July 2004<http://www.cdc.gov/nip/publications/fs/gen/WhatIfStop.htm>.

36 Ibid.

37 “Summary of Notifiable Diseases — UnitedStates, 2002” Morbidity and Mortality WeeklyReport: 53 (2004): 16-17.

38 “What Would Happen If We StoppedVaccinations,” Centers for Disease Control andPrevention. 9 July 2004 <http://www.cdc.gov/nip/publications/fs/gen/WhatIfStop.htm>.

39 Ibid.

40 National Immunization Program: VaricellaVaccine — FAQs Related to Pregnancy,”Centers for Disease Control and Prevention,(15 February 2001) <http://www.cdc.gov/nip/vaccine/varicella/faqs-cl inic-vac-preg.htm#2-congenital> 30 July 2004.

41 Ross Rapoport, “CDC: Immunizations HighBut Shot In Arm Still Needed,” Cox NewsService. 1 August 2003.

42 Zhou, et al, “Economic Evaluation of RoutineChildhood Immunization with DTaP, Hib,IPV, MMR and Hep B Vaccines in the UnitedStates,” Pediatric Academic SocietiesConference, Seattle, Washington, May 2003.

43 Ibid.

44 Ibid.

45 J.A. Califano, Governing America: An Insider’sReport From the White House and the Cabinet.(New York: Simon and Schuster, 1981).

46 “The Birth of Every Child By Two,” EveryChild By Two. <http://www.ecbt.org/back-grd.htm.> 29 July 2004.

47 Alan Hinman, Walter Orenstein, et al.,“Childhood Immunization Laws that Work,”Journal of Law, Medicine & Ethics: 30.3 (22September 2002).

48 A resource of state laws, published by theNational Network for ImmunizationInformation.can be found at<http://www.immunizationinfo.org/vaccineInfo/index.cfm#state>.

49 Immunization Information for theEcumenical Child Care Community.(Washington, D.C.: Every Child by Two,January 2003).

50 “National, State, and Urban Area Vaccinationcoverage Among Children Aged 19-35 Months- United States, 2003.” Morbidity and MortalityWeekly Report: 53 (30 July 2004): 658-661.

51 Janet McConnaughey, “Louisiana NearBottom of List for Child Immunization,”Associated Press, 31 July 2003.

52 “National, State, and Urban Area Vaccinationcoverage Among Children Aged 19-35 Months— United States, 2003.” Morbidity and MortalityWeekly Report: 53 (30 July 2004): 658-661.

53 Ibid.

54 “Estimated Vaccination Coverage with 4:3:1:3:3Among Children 19-35 Months of Age byRace/Ethnicity and by State and ImmunizationAction Plan Area — US, NationalImmunization Survey, 2003, Centers for DiseaseControl, National Center for Health Statistics<http://www.cdc.gov/nip/coverage/nis/03/tab29_43133_race_iap.xls> 22 July 2004.

55 Beverly M. Gaines, “Low Vaccination RatePuts Blacks at Risk,” New Pittsburgh Courier,25 September 2002.

56 National Immunization Program 2003Annual Report — Immunization: A StrongFoundation for Today’s Challenges (Atlanta:Centers for Disease Control and Prevention,2004): 7 <http://www.cdc.gov/nip/webu-t i l / a b o u t / a n n u a l -rpts/ar2003/6priorities.pdf> 3 August 2004.

25

57 N.R. Saltmarsh, “Childhood Immunization:Medicaid Managed Care Does Not EnsureUp-to-date Vaccination Status,” Health &Medicine Week, 13 August 2001.

58 Development of Community and State-BasedImmunization Registries (Washington, D.C.:National Vaccine Advisory Committee, 12January 1999): 10.

59 “The Measles Epidemic: The Problems,Barriers, and Recommendations,” Journal ofthe American Medical Association: 266 (1991):1547-1552.

60 W. Atkinson, C. Wolfe, S. Humiston, R.Nelson, eds. Epidemiology and Prevention ofVaccine-Preventable Diseases, 6th ed.(Atlanta: Centers for Disease Control andPrevention, 2000).

61 “Whooping Cough Maintains its Presence inWisconsin,” Wisconsin Department of Healthand Family Services<http://www.dhfs.state.wi.us/News/PressReleases/2004/071604Pertussis.htm> 3 August 2004.

62 “Pertussis Outbreak Sickens 107 in Chicagoarea,” ABC 7 News 8 July 2004 <http://abclo-cal.go.com/wls/news/070804_ap_ns_whoop-ingcough.html> 3 August 2004.

63 Calling the Shots: Immunization FinancePolicies and Practices. (Washington, D.C.:Institute of Medicine, 2000).

64 Ibid.

65 Congress established the Vaccines forChildren Program (VFC) in 1994 to betterensure equal access to immunizations for allchildren. The VFC program is a state-operat-ed, federal entitlement program that removesvaccine cost as a barrier to immunization forpoor children. Over 43,000 provider sites areenrolled in the VFC program, and 73 percentof these are private provider sites. The VFCprogram provides public-purchased vaccinesto all enrolled providers who agree to vacci-nate VFC-eligible children.Children frombirth to age 18 are eligible for VFC if they areMedicaid-eligible, without health insurance,American Indian or Alaska Native.Additionally, children with health insurancethat does not cover vaccines are eligible if theyare served through a federally qualifiedhealth center. From the 2003 Annual Reportfor the Centers for Disease Control andPrevention’s Immunization Program: 34.

66 Other federal programs include the PublicHealth Service Act 317(d) categorical aidprogram, the Maternal and Child HealthBlock Grant, and other, smaller programs.

67 Financing Vaccines in the 21st Century:Assuring Access and Availability, (Washington,D.C.: Institute of Medicine, August 2003).


69 Ibid.

70 Financing Vaccines in the 21st Century:Assuring Access and Availability, (Washington,D.C.: Institute of Medicine, August 2003).

71 Ibid.

72 Ibid.

73 Strengthening the Supply of RoutinelyRecommended Vaccines in the United States,(Washington: D.C.: U.S. Department ofHealth and Human Services, NationalVaccine Program Office, January 2003).

74 Ibid.

75 Financing Vaccines in the 21st Century:Assuring Access and Availability,(Washington, D.C.: Institute of Medicine,August 2003).

76 Michele G. Sullivan, “Public Sector Cost ofChildhood Immunizations Set to Skyrocket,”Family Practice News: 32.12 (15 June 2002)[Anywhere from three to seven new vaccinesare anticipated over the coming decadesaccording to three national reports].

77 Strengthening the Supply of RoutinelyRecommended Vaccines in the United States,(Washington: D.C.: U.S. Department ofHealth and Human Services, NationalVaccine Program Office, January 2003).

78 Calling the Shots: Immunization FinancePolicies and Practices. (Washington, D.C.:Institute of Medicine, 2000.


80 “National, State, and Urban Area VaccinationCoverage Levels Among Children Aged 19—35 Months - United States, 1998,” Morbidityand Mortality Weekly Report: 49 (22September 2000): 9.

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82 “Immunization Registry Progress - United States,January - December 2002,” Morbidity andMortality Weekly Report: 53 (28 May 2004): 431-433 <http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5320a3.htm> 7 June 2004.

83 Recent research has debunked many fearsthat vaccines can cause certain childhood dis-orders: — Autism: In 1998 a British doctorurged a follow-up of his earlier observationthat the MMR vaccine might, in rare cases,cause such behavioral problems as autism bytriggering an intestinal disorder like Crohn’sdisease. He had based his conjecture on asmall group of cases -—12 children. Sincethen, several large-scale investigations in theU.S., England, and Finland have shown thatneither Crohn’s disease nor autism occursmore often following immunization.

• Brain damage: In children six months to fiveyears old, a fever can trigger brief seizures markedby jerking or stiffness. Two vaccines — the MMRand the diphtheria-tetanus-pertussis (DTP) —commonly cause fever and thus, in a small num-ber of cases, seizures. These fever — related inci-dents occur in one in 3,000 children vaccinatedagainst MMR and one in 1,700 kids inoculatedwith the old, whole-cell DTP vaccine. (The rate ismarkedly lower with the newer, “acellular” DTaPvaccine: one in 14,000 children.) In the vastmajority of cases, convulsions caused by fever inyoung children do no lasting harm — althoughthey can be frightening to parents. In about 1 ina million cases, though, these seizures are fol-lowed by epilepsy, coma, or mental impairment.In such instances, some researchers suspect, thefever simply unmasked an underlying condition:If the vaccine-related fever hadn’t triggered theonset of the disorder, another fever would havedone so. There hasn’t been enough research toknow for sure whether this is true, and in rareinstances, seizures are not fever induced.

• SIDS (sudden infant death syndrome): Anti-vaccine groups also claimed that whole-cellDTP increased the risk of SIDS, but large stud-ies have found that immunized infants actual-ly have a slightly lower risk.

• Allergies: In the 1990s one hypothesis explain-ing the rise in the rates of allergic diseases, suchas hay fever, asthma, and eczema, was that bet-ter hygiene was shielding children from thegerms they needed to “educate” their immunesystem to distinguish harmless substances like

pollen and dust from more harmful bacteriaand viruses. Some scientists wondered whethervaccines might contribute to that by preventingkids from contracting “normal” childhood dis-eases. A recent study of immunization rates at91 medical centers in 38 countries put suchconcerns to rest, showing no associationbetween vaccination and the incidence of aller-gic diseases in children ages six to seven. In aseparate study of children ages 13 to 14, thosewith the highest immunization rates actuallyhad lower rates of allergic conditions.

• Juvenile diabetes: In 1997, an immunologisttheorized that the timing of the flu vaccinemight have an influence on the occurrence ofType 1 diabetes. But a 2001 study conductedby the Centers for Disease Control andPrevention (CDC) compared infants whodeveloped diabetes with those who did notfound no link between the time the vaccinewas given and the disease.

• Weakened immunity: One of the charges lev-eled most frequently by anti-vaccine activists isthat too many immunizations can overwhelm ayoung child’s developing immune system. Thistheory is currently being investigated by theImmunization Safety Review Committee, creat-ed by the CDC and the Institute of Medicine ofthe National Academies of Science. But pedi-atric immunologist Richard Johnston, M.D., atthe University of Colorado School of Medicinesays that taken together, the purified antigens(compounds that stimulate an immuneresponse, which protects against the real dis-ease) in all of the recommended childhoodvaccines represent a mere drop in the oceancompared to what small children are exposedto in their daily lives. And many studies havefound that when several vaccines are combinedinto one shot — standard practice — no majoradverse side effects have been detected.

84 Jessica Snyder Sachs; Nichole Cipriani,“Vaccine Safety: Recent Recalls and RumorsHave You Wondering Exactly What the RisksAre? Here’s What You Need to Know Now,”Parenting. April 2002.

85 Ibid

86 Deborah A. Gust, Tara W. Strine, MauriceEmmanuel, Philip Smith, “UnderimmunizationAmong Children: Effects of Vaccine SafetyConcerns on Immunization Status.” Pediatrics.114. (1 July 2004).

87 Immunization Safety Review: Vaccines andAutism, (Washington, D.C.: Institute ofMedicine, 2004). <http://www.iom.edu/report.asp?id=20155> 29 July 2004.

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88 Of all deaths reported to VAERS between1990 and 1992, only one is believed to beeven possibly associated with a vaccine.<http://www.cdc.gov/nip/publications/6mishome.htm> 29 July 2004.

89 “Initiative on Immunization Registries,”Morbidity and Mortality Weekly Report: 50 (5October 2001): 1-17.

90 Ibid.

91 “Strategies to Sustain Success in ChildhoodImmunizations,” Journal of the AmericanMedical Association: 282.4 (1999): 24.

92 BG Gellin, EW Maibach, EK Marcuse, “DoParents Understand Immunizations? ANational Telephone Survey,” Pediatrics:106.5 (2000):1097-1102.

93 “Facts about Childhood Immunization,”Centers for Disease Control and Prevention<http://www.cdc.gov/nip/webutil/about/annual-rpts/ar2004/commit-ed-comm.rtf> 29July 2004.

94 Karen Auge, “State Vaccinations Lag:Colorado Ranks Last Nationwide inChildhood Inoculations,” Denver Post, 1August 2003.

95 “At Denver Health, 81% to 84% coverage -‘we do quite a bit better than the state,’ sayspediatrician Mark Anderson. It is estimatedthat a state-wide registry would cost $1 mil-lion.” Karen Auge, “State Vaccinations Lag:Colorado Ranks Last Nationwide inChildhood Inoculations,” Denver Post, 1August 2003.

96 Karen Auge, “State Vaccinations Lag:Colorado Ranks Last Nationwide in ChildhoodInoculations,” Denver Post, 1 August 2003.

97 Ibid.

98 “State Pursuing Aggressive Effort to ImproveImmunization Rate,” Colorado Departmentof Public Health and Environment.<http://www.cdphe.state.co.us/release/2004/072904.html> 30 July 2004.

99 James Todd, Steve Berman, Carl Armon, State ofthe Healthy of Colorado’s Children. (Denver:The Children’s Hospital, August 2004).

100 Karen Auge, “State Vaccinations Lag:Colorado Ranks Last Nationwide inChildhood Inoculations,” Denver Post, 1August 2003.

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